Dabigatran Etexilate Mesylate
Average across 8 priced NDCs. A benchmark of pharmacy acquisition cost - not a retail quote.
Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume - Medicaid only, not all-payer.
US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| Major Pharmaceuticals | relabeler | 5 | SUPPLYING |
| Ascend Laboratories, LLC | generic | 4 | SUPPLYING |
| A-S Medication Solutions | repackager | 2 | SUPPLYING |
Shortages, recalls, and registration changes attached to this drug concept.
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability — Recalling firm: Ascend Laboratories, LLC — USA Nationwide
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability — Recalling firm: Ascend Laboratories, LLC — USA Nationwide
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability — Recalling firm: Ascend Laboratories, LLC — USA Nationwide
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability. — Recalling firm: Ascend Laboratories, LLC — USA Nationwide
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability. — Recalling firm: Ascend Laboratories, LLC — USA Nationwide
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit — Recalling firm: Ascend Laboratories, LLC — Nationwide within the United States
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit — Recalling firm: Ascend Laboratories, LLC — Nationwide within the United States
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit. — Recalling firm: Ascend Laboratories, LLC — Nationwide in the USA.
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit. — Recalling firm: Ascend Laboratories, LLC — Nationwide in the USA.
